PMA P010041S036
- Device
- CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2012-10-04
- Generic name
- replacement Heart-valve
- Approval order statement
- MANUFACTURING SOFTWARE CHANGE TO AUTOMATE IN-PROCESS LABELING.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S036
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2012-10-04
- Decision code
- OK30
- Date received
- 2012-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING SOFTWARE CHANGE TO AUTOMATE IN-PROCESS LABELING.